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Actos News
2013
Jury rules Takeda not Liable in Third Actos Bladder Cancer Trial
Dec. 16, 2013
A jury in Las Vegas has ruled in favor of defendant Takeda Pharmaceutical America, Inc., in the third Actos bladder cancer lawsuit to go to trial. Jurors found Takeda not liable for causing Allen Alsabagh's bladder cancer, which was diagnosed in 2011. This is the first trial in which jurors did not find Takeda negligent for failing to properly warn the plaintiff of the link between Actos, a diabetes drug manufactured by Takeda, and bladder cancer.
The third Actos bladder cancer lawsuit began in the Clark County District Court in Las Vegas, Nevada on November 18, 2013. The lawsuit charges Takeda Pharmaceuticals with failing to warn patients and health care providers that Actos may cause bladder cancer. In both previous Actos trials, juries have found that Takeda acted negligently in concealing the risk of bladder cancer from the plaintiffs and their physicians. Last April, a jury in Los Angeles awarded $6.5 million to a California man with terminal cancer and his wife. A second trial in Baltimore recently concluded with a jury award of $1.7 million to the family of a man who died of bladder cancer. Though the presiding judges nullified both jury awards and the cases are on appeal, the road ahead for Takeda looks increasingly grim.
Takeda Battles European Regulatory Authorities’ Push for Clinical Testing of Actos
Exhibit from first Actos trial
Admitted into evidence during the March 2013 Jack Cooper Actos trial, this document is the 2002 battle plan from Takeda international on how Takeda European division successfully fended off a bladder cancer warning—see last slide re: assert the Cohen hypothesis and “don’t turn over any stones.”
Actos Whistleblower States the Case Against Takeda
Exhibit from first Actos trial
Dr. Helen Ge is a medical doctor and former safety consultant to Takeda. Baum Hedlund Aristei & Goldman filed Dr. Ge’s qui tam action (a lawsuit brought by a private party on behalf of the government) in 2010 under the federal False Claims Act. The lawsuit alleges that Takeda intentionally made false statements to, and withheld facts from, the Food and Drug Administration in an effort to maximize profits from its diabetes drug, Actos. This opening brief lays out the basis of Dr. Ge’s lawsuit.
Takeda Surveys Doctors. Bladder Cancer: What if They Found Out?
Exhibit from first Actos trial
This exhibit contains the 2003 results of a survey Takeda did on physicians after Takeda was approached by the FDA to make a labeling change to reflect the risk of bladder cancer shown in drugs very similar to Actos. Doctors said if a bladder cancer risk was added to the label, they would not prescribe it to their diabetic patients. (See pages 75-77 of the document.) This document was admitted as evidence in the first Actos trial in March 2013 on behalf of Jack Cooper.
FDA Tells Takeda Public not Adequately Informed About Bladder Cancer Risks
Exhibit from first Actos trial
These conference call notes were admitted as evidence in the first Actos trial in March, 2103. They summarize a July 31, 2002 conversation FDA Toxicology Team Leader Jeri El-Hage had with Takeda (TPNA = Takeda Pharmaceuticals of North America) explaining the bladder cancer link to Actos shown in non-clinical trials of similar compounds. In those trials, 85% of the animals exposed to Actos had tumor formation. Dr. El Hage told Takeda representatives that the FDA believed the public was not being adequately informed about the bladder cancer risk associated with drugs like Actos.
Exhibit 20, which became available during the first Actos bladder cancer trial brought by Jack Cooper, is a 2005 email exchange between Takeda Japan executives and Takeda U.S. executives regarding how to deal with the bladder cancer issue. The document suggests that Takeda’s principal goal was to protect the “product” (instead of people) and that providing a bladder cancer warning would be a worst case scenario for the drug maker.
Takeda to Actos Reps: Don’t Tell – Sell, Sell, Sell
Exhibit from first Actos trial
As a result of the first Actos trial, Exhibit 26 was made available to the public. Exhibit 26 is a sales team power point for Takeda sales reps attending an American Diabetic Association conference for health care professionals (HCPs).The 9th page of the attachment, “Sales Force Verbatim,” shows a middle bullet point regarding what to tell physicians attending the conference about the Actos bladder cancer issue: Don’t tell - sell, sell, sell.
According to several sources (including Bloomberg News and pharmalive.com), a Maryland state court jury yesterday ordered Takeda to pay $1.7 million in damages to the family of a former U.S. Army translator who died of bladder cancer in 2012. Diep An began taking Actos in 2007 and was diagnosed with bladder cancer in September 2011. The jury found that Takeda negligently failed to adequately warn An’s doctor of the risk of bladder cancer from Actos and that the failure to warn was a substantial factor in causing An to develop the disease.
Bloomberg reports that the lawyer trying the second Actos case to go to trial is accusing Takeda of putting sales ahead of safety. The trial began on August 27, 2013 in Baltimore, Maryland.
The United States government and a nationally recognized law firm representing individuals suffering from bladder cancer after ingesting Actos have filed amicus briefs* that support Dr. Helen Ge’s whistleblower claims. Dr. Ge is suing drug maker Takeda Pharmaceuticals for submitting false claims related to Medicare and Medicaid reimbursement costs for its diabetes drug, Actos. Ge, a medical doctor and former safety consultant to Takeda, worked for the company reviewing adverse drug events related to Actos and other drugs, but her contract was terminated following conflicts regarding her medical assessments concerning bladder cancer and congestive heart failure.
India Suspends the Sale of Actos
Thursday, June 27, 2013
Regulators in India have suspended the sale of Actos (pioglitazone), a type 2 diabetes drug manufactured by Takeda Pharmaceuticals. The decision follows in the footsteps of France and Germany, both of which suspended sales of Actos in 2011 due to a link between the drug and an increased risk of bladder cancer. Actos carries a black box warning in the United States due to the bladder cancer link. Thousands of people in the U.S. diagnosed with bladder cancer after taking Actos have filed lawsuits against Takeda. The number of claims Takeda might face is estimated to be as high as 10,000.
A $6.5 jury award against Takeda Pharmaceuticals for failing to warn a California man and his physician of the risk of bladder cancer associated with Takeda’s diabetes drug Actos was overturned Friday by the presiding judge. But Takeda’s troubles may be just beginning.
In its complaint against Actos manufacturer Takeda Pharmaceuticals, counsel for plaintiff Jack Cooper alleged that Takeda acted negligently in the selling, advertising, marketing and promotion of its diabetes drug by failing to warn physicians and consumers of the risk that Actos could cause bladder cancer. Jurors in the trial that concluded Friday agreed, awarding $6.5 million dollars to Cooper and his wife.
During the trial, plaintiff’s counsel Michael Miller argued that Takeda had known of research linking Actos to bladder cancer since at least 2004, but to protect their profits ($4.5 billion in 2011 from Actos sales), the company consistently thwarted the numerous Food and Drug Administration’s attempts to revise the drug’s product label to notify doctors and patients of the risk. Studies also suggested that the risk was increased the longer one took the diabetes drug, making the timing of a label change even more significant. Cooper began taking Actos (pioglitazone) in late 2006. It wasn’t until 2011 that a bladder cancer warning was finally added to the label.
A Los Angeles jury has awarded $6.5M to Jack Cooper, a California man who claimed his bladder cancer was the result of the Actos medication he was taking for his diabetes.
Mr. Cooper’s case was the first Actos bladder cancer case to go to trial and was given priority because his doctor had given him only a few months to live. This verdict will set the bar for the thousands of other plaintiffs’ cases waiting to go to trial.
In closing arguments yesterday, Mr. Cooper’s attorney told jurors that Takeda was aware of the bladder cancer risk as early as 2004 (Cooper began taking Actos in September 2006) but carried out a carefully executed plan, revealed in emails and other internal documents, to hide the risk in order to protect a drug that was making $1.6 billion a year.
In a report filed with the court, plaintiff’s expert James Morrison stated that a prominent clinical trial involving Actos, known as the PROactive study and published in The Lancet in October, 2005, demonstrated a link between the drug and bladder cancer – a link that Takeda concealed in its Lancet paper.
Baum, Hedlund, Aristei & Goldman has filed a new Actos bladder cancer lawsuit on behalf of four plaintiffs and three of their spouses against Japanese drug manufacturer Takeda Pharmaceuticals and its subsidiaries, alleging that the diabetes medication caused their bladder cancer. Eli Lilly, which launched Actos along with Takeda in 1999, is also listed as a defendant in the bundled complaint.
Following meetings with Takeda, the FDA sought to add language to the Actos label stating that “a receptor-mediated mechanism for tumor induction cannot be ruled out” with PPAR agonists. Takeda resisted, claiming that “current evidence was insufficient to justify the proposed label change.”
Depositions taken by Takeda of two key plaintiff’s witnesses suggest that the drug maker may employ a “just following orders” strategy in its defense, arguing it did everything the Food and Drug Administration (FDA) required in terms of the Actos label, and therefore, if the label did not fully convey the bladder cancer risk associated with Actos, the FDA, not Takeda, should be held liable.
Dr. Howard Greenburg, an expert in pharmacology and drug regulation, was questioned about internal Takeda emails that he says demonstrate the drug maker’s intent to forestall label changes that would have warned of an Actos-bladder cancer link, a change that Takeda knew would seriously damage sales of its top selling drug.
One of the central allegations in the ongoing Actos bladder cancer trial is that Actos manufacturer Takeda has long known that its diabetes drug caused bladder cancer in patients but chose not to warn consumers or the medical community.
Attorneys have delivered their opening statements in the first Actos bladder cancer trial which is currently underway in California state court. The Actos case, brought by plaintiff Jack Cooper against Osaka, Japan-based Actos manufacturer Takeda Pharmaceuticals, began on February 19, 2013 at the Central Civil West Courthouse, Superior Court of California in Los Angeles. It is the first trial of thousands of similar pending lawsuits alleging that the blockbuster diabetes drug Actos led to an increased risk of developing bladder cancer.
The attorney for a California man who claims he developed terminal bladder cancer as a result of taking the diabetes drug Actos delivered opening remarks in California state court on Thursday, February 28. The case is the first of thousands of similar Actos bladder cancer lawsuits nationwide to go to trial. Plaintiff’s attorneys used their opening statement to lay out a timeline of actions taken by Actos manufacturer Takeda Pharmaceuticals that demonstrate a consistent effort to conceal from doctors and patients scientific evidence linking Actos to bladder cancer.
Takeda Pharmaceuticals, the manufacturer of diabetes drug Actos (pioglitazone), saw sales of the drug plummet by over 50 percent at the end of last year. The dramatic drop in sales was mainly due to U.S. and European regulatory agencies issuing safety warnings linking Actos to an increased risk of bladder cancer.
Now that the patent on Actos has expired, Takeda is apparently looking for other sources of revenue. Actos, once one of the most widely-prescribed drugs in the world, has been replaced by Nesina (alogliptin), and Takeda has high hopes for its success. Surprisingly, the U.S. Food and Drug Administration approved Nesina, along with combination drugs Kazano and Oseni, the latter of which contains pioglitazone.
A new study published in the January edition of Diabetic Medicine confirms myriad other studies in recent years linking diabetes drug Actos (pioglitazone) to an increased risk of developing bladder cancer. The study, which looked at data from over 215,000 patients taking Actos, showed that "the hazard of developing bladder cancer was significantly higher in patients using pioglitazone." The elevated hazard ratio of 1.23 compared to control groups in the study led researchers to advise doctors against prescribing the drug to certain patients.
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